A US federal court has entered a consent decree of permanent injunction against medtech giant Philips and its various subsidiaries preventing the company from re-entering the positive airway pressure (CPAP) machine and bi-level positive airway pressure (BiPAP) machine market until requirements are met.
The permanent injunction levelled against Philips comes following a series of class one recalls, the most serious kind, and numerous device failures in its CPAP and BiPAP range.
The devices have suffered various problems from overheating to foam particles loosening and becoming a hazard, alongside evidence that Philips had been aware of the defects in its ventilator devices for years before issuing the 2021 recall which alerted the US Food and Drug Administration (FDA).
Now, the complaint, filed by the Department of Justice on behalf of the FDA before the District Court of Western Pennsylvania, claims that Philips Respironics violated the Federal Food, Drug, and Cosmetic Act by introducing devices into the market deemed to have been adulterated because they were not manufactured in accordance with good manufacturing practise requirements.
The decree also requires the implementation of a Recall Remediation Plan agreed to by the FDA and Philips Respironics that aims to ensure that patients impacted by the original 2021 recall of Philips ventilators receive some kind of new device or refund.
Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said: “The finalisation of this decree is a significant milestone. Throughout this recall, we have provided patients with important health information by issuing numerous safety communications and have taken actions rarely used by the agency to help protect those impacted by this recall.
“This action is a culmination of those efforts and includes novel provisions aimed at helping ensure that patients receive the relief they have long deserved. This also marks the first time a device company is providing a remediation payment option for a recalled device under a consent decree.”
The decree also claims that Philips further broke FDA regulations by introducing devices into interstate commerce that are misbranded because Philips failed to provide the FDA with information about specific corrections or removals made to devices.
As a result, with a few small exceptions, the consent decree restricts Philips and its subsidiaries from manufacturing and distributing devices at or from the Philips Respironics facilities in Pennsylvania and California, until the company has completed the repair, rework, replacement and refund activities set forth by the FDA in the Recall Remediation Plan.
The company must receive written notice from the FDA that it is compliant these requirements before resuming operations.
Additionally, Philips is now required to reach out to patients and medical device providers to inform them of actions they are permitted to take in seeking a replacement or refund from the company.
